Apply on Employer Site

Penumbra, Inc. · 21 hours ago

QA Supervisor - DHR Review

Roseville, CA

Full-time

Onsite

Entry, Mid Level

$71K/yr - $98K/yr

2+ years exp

Penumbra, Inc. is a global healthcare company focused on innovative therapies. As a QA Supervisor of DHR Review, you will oversee the DHR Review areas of the Quality System and manage the DHR Reviewers, ensuring compliance and system effectiveness while supporting internal and external audits.

Medical Device

H1B Sponsor Likely

Responsibilities

Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans

Manage the scheduling of DHR Reviewers for coverage, prioritization and workload

Coordinate with internal customers to establish prioritizations and work though discrepancies

Communicate and train internal customers when processes are changed

Complete DHR Review when needed

Analyze and generate trending data to support system effectiveness

Evaluate procedures and work instructions for processing improvements and implement changes as necessary

Support Quality System processes during internal and external regulatory audits

Proactively seek system improvements while maintaining compliance to applicable requirements

Communicate Quality System issues to upper management, presenting solutions as appropriate

Qualification

Medical Device regulationsSupervisory experienceMicrosoft OfficeProblem solvingOrganizational skills

Required

A Bachelor's degree with 2+ years of experience, or equivalent combination of demonstrated education and experience

Proficiency with Microsoft Office (e.g., Word, Excel, Access, PowerPoint, etc.)

Demonstrated working knowledge of Medical Device regulations

Solid problem solving, decision-making, and supervisory skills required

High degree of accuracy and attention to detail

Excellent organizational skills with ability to prioritize assignments while handling various assignments simultaneously

Preferred

Prior supervisory experience preferred

Benefits

Medical

Dental

Vision

Life

AD&D

Short and long-term disability insurance

401(k) with employer match

An employee stock purchase plan

Paid parental leave

Eleven paid company holidays per year

A minimum of fifteen days of accrued vacation per year, which increases with tenure

Paid sick time in compliance with applicable law(s)

Company

Penumbra, Inc.

Glassdoor3.3

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

Founded in 2004

Alameda, CA, US

1001-5000 employees

http://www.penumbrainc.com

H1B Sponsorship

Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (36)

2024 (42)

2023 (46)

2022 (43)

2021 (36)

2020 (26)